Connector for packaging containing medical fluids and packaging for medical fluids

ABSTRACT

The disclosure relates to a connector for packaging containing medical fluids, in particular infusion or transfusion bags, including a tubular connection part for receiving a spike for the withdrawal of fluid, and having a lower opening on the packaging side and an upper opening on the connection side. A self-sealing membrane, which is pierced by the spike, is located in the connection part. The membrane has an upper, annular section leading into a lower, plate-shaped section, said annular section of the membrane surrounding the spike in a sealing manner, when the latter pierces the plate-shaped section. The membrane acts as a guide for the spike and also reseals the connector, once the spike has been removed.

The invention relates to a connector for packaging containing medicalfluids, in particular infusion or transfusion bags, which serves toextract a fluid from the bag. Moreover, the invention relates topackaging for medical fluids, in particular an infusion or transfusionbag, with such a connector.

WO 96/23545 describes an infusion bag with an injection part and anextraction part. The injection part serves to feed a drug by means of aninjection syringe. It comprises a tubular connection part, which issealed by a protective cap designed as a break-off part. A self-sealingseptum sits in the opening area of the connection part, whilst amembrane capable of being pierced is arranged in the connection part, sothat the septum does not come into contact with the solution before theuse of the infusion bag. The extraction part serves to extract thesolution by means of a spike. The extraction part does not have aself-sealing septum, otherwise the structure is similar to that of theinjection part.

A connector for the extraction of an infusion solution is also describedin DE 197 28 775 C2. The tubular connection part of the known extractionpart is sealed by a flat membrane, which is in one piece with theconnection part.

The known extraction parts have been tried and tested in practice. Adrawback, however, consists in the fact that the infusion bag is notsealed again after the spike has been withdrawn. There is therefore therisk of the infusion solution running out. This is particularly criticalafter the addition of cytostatic drugs.

A further drawback is that the connection between the spike and theextraction part is not secured against slipping out. When the bag ishanging on the stand, there is the risk of the connection of the spikearid the extraction part being separated due to unintentional tugging onthe flexible-tube line.

There is also the drawback that the injected membrane, which seals theconnection part of the extraction part, does not always withstandgreater mechanical loads. Thus, it has been shown in drop tests that themembrane of individual extraction parts ruptured.

The problem underlying the invention is to provide a connector forpackages containing medical fluid, in particular infusion or transfusionbags, which reliably seals the packaging after the withdrawal of thespike.

The solution to this problem takes place according to the invention withthe features of claim 1. Advantageous forms of embodiment of theinvention are the subject-matter of the sub-claims.

The connector according to the invention has a self-sealing membrane,which is arranged in the connection part for accommodating the spike forthe extraction of the fluid. The self-sealing membrane prevents thefluid from running out of the packaging after withdrawal of the spike.

It is advantageous that the self-sealing membrane has a circularportion, which transforms into a dish-shaped portion, whereby thecircular portion of the membrane surrounds the spike in a sealed mannerwhen it pierces the dish-shaped portion.

The special formation of the membrane with the circular and dish-shapedportion on the one hand ensures that the spike is guided reliably whenit pricks the membrane and on the other hand guarantees that themembrane is again reliably sealed after withdrawal of the spike even inthe presence of relatively high internal pressure in the packaging. Ithas been shown in tests that the special formation of the membrane isdecisive for immediate re-sealing, whereby the sealing of the membraneis further enhanced with increasing pressure in the packaging. Thereliable sealing can be traced back not to the volume of material, butto the special geometry of the membrane.

In a preferred form of embodiment of the connector according to theinvention, the material of the dish-shaped portion of the membrane isweakened, so that the membrane can be particularly easily pierced by thespike. The membrane is preferably pre-slit in the form of a cross. Itcan also be pre-slit in the form of a star or suchlike or only beprovided with a simple slit.

In a particularly preferred form of embodiment, the tubular connectionpart of the connector consists of a lower and an upper section, wherebythe sections are fixed in a snap-in manner. The self-sealing membrane ispreferably held clamped with elastic deformation of the same between thelower and upper section. Consequently, the fitting of the connector canbe carried out in a straightforward manner by pressing of the individualparts. It is however also possible for the individual parts to be weldedand/or glued together.

A further particularly preferred form of embodiment makes provision suchthat an outer portion, which is clamped between the two sections,follows on from the circular portion of the membrane.

In order to prevent the self-sealing membrane in the tubular connectionpiece from coming into contact with the solution contained in theinfusion and transfusion bag prior to the use of the latter, a secondmembrane capable of being pierced is preferably arranged beneath theself-sealing membrane thereby forming an intermediate space. The secondmembrane is expediently a one-piece component of the tubular connectionpiece.

It has been shown in tests that the use of a membrane curved upwards ordownwards instead of a flat membrane leads to an increase in dropstrength. Since the second membrane is designed curved upwards ordownwards, the connector according to the invention withstandsrelatively great mechanical loads. Apart from the increase in dropstrength, there is also the advantage that the spike in the piercedposition is held clamped by the curved membrane. The retention force ofthe spike in the withdrawal position is thus increased, as a result ofwhich unintentional slipping out is prevented.

In order to secure the upper and lower part of the connection pieceagainst radial torsion, both parts can have toothing or suchlike, whichalso ensures precise alignment of the parts during pressing together.Furthermore, the risk of damage to the two membranes is especially lowduring the pressing together of the individual parts.

The break-off sealing part of the connector, which serves as anoriginality seal, is preferably connected to the connection part via acircular rupture zone.

Since the break-off sealing part preferably has a grip part, which isdesigned in the manner of an arrow pointing upwards, it can immediatelybe recognised that the connector is an extraction part, but not aninjection part. Preferably, the arrow is a recess in the grip part,which is immediately recognisable without lettering or suchlike beingnecessary. Confusion between the extraction and injection part of apackage containing medical fluids can thus be avoided.

The lower part of the connection piece also preferably has an arrowpointing upwards, which is designed as a raised structure, preferably ina recessed grip. The upward-pointing arrow of the lower connection-piecepart also permits the connector to be unequivocally assigned as theextraction part after breaking-off of the sealing part.

An example of embodiment of the invention is explained in greater detailbelow by reference to the drawings.

The figures show the following:

FIG. 1 a connector designed as an extraction part for packagescontaining medical fluids in sectional representation,

FIG. 2 an infusion bag with the extraction part of FIG. 1 and aninjection part and

FIG. 3 the injection part of the infusion bag of FIG. 2 in sectionalrepresentation.

Connector 20 designed as an extraction part for packages containingmedical fluids, in particular infusion or transfusion bags, has atubular connection part 1, which consists of a package-side lowersection 2 and a connection-side upper section 3. Tubular connection part1 therefore has an upper and a lower opening 1 a, 1 b. Connector 20 isan injection-moulded part made of polypropylene.

Lower section 2 of tubular connection part 1 has a lower cylindricalportion 4, which transforms into an upper sleeve-shaped portion 5.Cylindrical portion 4 of lower section 2 can be inserted into aconnection socket of a film bag and can be welded or glued to the socketor be directly welded into the film bag without a socket. Cylindricalportion 4 is sealed at its upper end with a membrane 6 capable of beingpierced, said membrane being a single-piece component of lower section2. The injected membrane is curved downwards. Alternatively, however,the membrane can also be curved upwards.

Upper section 3 of tubular connection part 1 is fixed in a snap-inmanner on lower section 2, whereby upper section 3 has a cylindricalportion 7 which surrounds lower section 2. The internal wall ofcylindrical portion 7 of upper section 3 has a peripheral groove 8, intowhich a peripheral projection 9 on the outer wall of sleeve-shapedportion 5 of lower section 2 snaps when the two sections 2, 3 arepressed together.

A self-sealing membrane 10 made of an elastic material, which is alsoreferred to as a septum, is held clamped with elastic deformation of thesame between the lower and upper section 2, 3 of tubular connection part1. Self-sealing membrane 10 has an outer portion 11, which is clampedbetween lower and upper sections 2, 3 of circular connection part 1.Outer portion 11 is followed by an upper circular portion 12, whichtransforms into a lower dish-shaped portion 14 thereby forming atrough-shaped recess 13 at the upper side of membrane 10. Dish-shapedportion 14 is pre-slit in the form of a cross or a star in centre 15, sothat the elastic material is weakened, but is not severed.

Upper section 3 of tubular connection part 1 is followed, via a circularrupture zone 31, by a cap-shaped sealing part 16, which seals upperopening 1 a of connection part 1. Sealing part 16 transforms into a flatgrip part 17, which is provided with a recess 18 in the shape of anarrow 19 pointing upwards. It can immediately be recognised from thedirection of arrow 19 that connector 20 is not injection part 40, butrather the extraction part.

The side view of connector 20 of FIG. 1 is shown in FIG. 2. FIG. 2 showsan infusion bag 21 filled with infusion solution, which has connector 24for the extraction of the infusion solution and a further connector 40for the injection of a solution into infusion bag 21.

On the outer wall of cylindrical portion 7 of upper section 3, tubularconnection part 1 of connector 20 has two recessed grips 21 lyingopposite one another, which are each formed by projecting webs 22 whichare arranged at a distance from one another. A further arrow 23, whichalso points upwards in order to identify connector 20 as the extractionpart, is formed as a raised structure on the outer wall of cylindricalportion 7 between webs 22.

Infusion bag 21 comprises two film layers 24, which are welded togetherat lower and upper edge 25, 26 and also at longitudinal edges 27, 28.Two connections sockets 29, 30 are welded into upper edge 25 of theinfusion bag. The tubular connection pieces of injection and extractionpart 40, 20 are inserted into connection sockets 29, 30 and connectedwith the sockets during sterilisation. The tubular connection pieces ofthe originality seals can however also be moulded onto an insert that isround or designed in the manner of a boat, said insert being welded inbetween the two film layers.

FIG. 3 shows injection part 40 of film bag 21 in a sectionalrepresentation. Injection part 40 has a similar structure to extractionpart 20. The parts corresponding to one another are therefore providedwith the same reference numbers. Injection part 40 has a tubularconnection part 1′, which consists of a lower and an upper section 2′,3′. The two sections 2′, 3′ are fixed in a snap-in manner with theinterposition of a self-sealing membrane 10′, whereby a projectingshoulder 8′ of lower section 2′ engages in a groove 9′ of upper section3′. Flat membrane 6′, which however can also be curved, is injected intolower section 2′.

Upper section 3′ of tubular connection part 1′ is again followed, via acircular rupture zone 31′, by a cap-shaped break-off part 16′, whichtransforms into a flat grip part 17′. An arrow 19′ pointing downwards isdesigned as a recess in grip part 17′. Arrows 23′ pointing downwards toindicate the flow direction are located on the outer wall of uppersection 3′ again inside recessed grips 21′.

For the extraction of infusion solution, break-off part 16 of extractionpart 20 is broken off by turning or breaking the same, so thatself-sealing membrane 2 is laid bare. The spike of a known transfersystem is pushed into tubular connection part 1 of extraction part 20,as a result of which pre-slit membrane 10 is pierced and membrane 6curved downwards is penetrated. Trough-shaped recess 13 serves as aguide for the spike. The spike is sealed by circular portion 12 ofmembrane 10. On account of the special formation of injected membrane 6,the spike is held firmly in tubular connection part 1.

The infusion solution can then be extracted. When the spike is againwithdrawn, self-sealing membrane 10 reliably seals extraction part 20even in the presence of a relatively high internal pressure. Moreover,the mechanical strength of extraction part 20 is increased by thespecial formation of injected membrane 6.

Injection part 40 serves. to inject an active substance into theinfusion solution. For this purpose, self-sealing membrane 10′ andinjected membrane 6′ are again pierced with the injection needle of asyringe after removal of break-off part 16′. The injection part is againsealed after withdrawal of the needle.

1. A connector for packages containing medical fluids, comprising atubular connection part for receiving a spike for the extraction of thefluid, the connection part having a package-side lower opening and aconnection-side upper opening, and a break-off sealing part which sealsthe connection-side opening of the connection part, a self-sealingmembrane disposed in the connection part, which can be pierced by thespike for the extraction of the fluid, said self-sealing membrane havinga circular upper portion, which transforms into a dish-shaped lowerportion to form a trough-shaped recess, wherein the circular portion ofthe membrane surrounds the spike in a sealed manner when the latterpierces the dish-shaped portion.
 2. The connector according to claim 1,wherein the material of the dish-shaped portion of the self-sealingmembrane is weakened.
 3. The connector according to claim 1, wherein thetubular connection part comprises a lower section and an upper section,wherein the sections are fixed in a snap-in manner.
 4. The connectoraccording to claim 3, wherein the self-sealing membrane is held clampedwith elastic deformation of the membrane between the lower section andthe upper section.
 5. The connector according to claim 3, wherein thecircular portion of the self-sealing membrane is followed by an outerportion, which is clamped between the lower section and the uppersection of the connection part.
 6. The connector according to claim 1,comprising a second membrane capable of being pierced disposed in theconnection part beneath the self-sealing membrane to form anintermediate space.
 7. The connector according to claims 6, wherein thesecond membrane capable of being pierced is a one-piece component of theconnection part.
 8. The connector according to claim 6, wherein thesecond membrane is curved upwards or downwards.
 9. The connectoraccording to claim 1, wherein the sealing part is connected via acircular rupture zone to the connection part.
 10. The connectoraccording to claim 1, wherein the sealing part has a grip partcomprising an arrow pointing upwards, wherein the arrow is a recess inthe grip part.
 11. The connector according to claim 1, wherein the lowerpart of the connection part comprises an arrow pointing upwards, whichis a raised structure.
 12. Packaging for medical fluids with a connectoraccording to claim
 1. 13. The connector according to claim 2, whereinthe material of the dish-shaped portion of the self-sealing membrane ispre-slit.
 14. The connector according to claim 11, wherein the arrow isdesigned as a raised structure in a recessed grip.
 15. Infusion bag witha connector according to claim
 1. 16. Transfusion bag with a connectoraccording to claim
 1. 17. A self-sealing membrane for use in extractionpoints for containers for medical fluids, comprising an innerdish-shaped section, which can be penetrated by a tubular extractiondevice, an outer circular section for the fixing of the membrane at theextraction point and an inner circular section which connects the outercircular section with the dish-shaped section, wherein the internaldiameter of the inner circular section diminishes towards thedish-shaped section, the inner circular section and the dish-shapedsection together form a trough-shaped recess and the inner circularsection surrounds the tubular extraction device in a sealed mannerduring the penetration of the dish-shaped section.
 18. A membraneaccording to claim 17, wherein the face of the inner upper sectionfacing the extraction device and running obliquely inwards includes twofaces with differing inclination, whereby the upper inclined face has asmaller inclination than the lower inclined face.
 19. The membraneaccording to claim 17, wherein the material of the inner dish-shapedsection is weakened.
 20. The membrane according to claim 19, wherein thematerial of the inner dish-shaped section is slit.